FDA Seeks Public Comments on Reporting Post-Market Adverse Drug Experiences

The Food and Drug Administration is seeking public comments on post-marketing adverse drug experience reporting and recordkeeping requirements, according to a notice published March 20 in the Federal Register (77 Fed. Reg. 16,232).

Those who have received marketing approval of drug products are required to report to FDA serious, unexpected adverse drug experiences, as well as follow-up reports when needed, the agency said. This includes reports of all foreign or domestic adverse experiences and those based on information from applicable scientific literature and certain reports from post-marketing studies.

Also, applicants must keep for 10 years the records of all drug ...